Low Level Light Device as a Primary Therapy for Androgenetic Alopecia

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Brief Title

Low Level Light Device as a Primary Therapy for Androgenetic Alopecia

Official Title

Evaluation of the GENIX, a Low Level Light Device as a Primary Therapy for Androgenetic Alopecia in Men and Women

Brief Summary

      The purpose of this research is to study the safety and effectiveness of a light therapy
      device for human hair growth. This device, called the GENIX, is a type of cold, or non-heat
      producing light emitting diode (LED) that will emit light on the hair growth cells within and
      around the hair follicle. When these cells do not function properly, one may experience
      common problems such as baldness and thinning or brittle hair. The application of a special
      category of low-level non-laser light to be studied in the project may cause an increase in
      essential nutrients to the damaged hair follicles and skin cells, leading to a reduction in
      hair loss and in some cases, possibly leading to re-growth.
    

Detailed Description

      The application of low-level light therapy has aroused considerable research interest in
      recent years for the treatment of a variety of clinical indications. These range from pain
      management to wound healing and most recently to hair regrowth. All have demonstrated
      biological effects in living organisms. In 1967 Endre Mester, a physician practicing in
      Budapest Hungary, decided to test the effects of laser radiation on mice and its possible
      link to resultant cancer. To his great surprise, the mice regrew the shaved hair in half the
      time of non-radiated mice. This was the first reference to LLLT and hair growth.

      This study on LLLT, aims to confirm the established safety and physiologic effects that occur
      when the human hair follicle and surrounding tissue structures are exposed to this type of
      radiation. Thus far, all reports on the efficacy of low level light therapy (LED) in this
      area, have been, in large part, consistent in outcome results, as supported by multi-center,
      randomized, double blind, controlled studies. This has been in the form of analysis of the
      non-radiated and radiated tissues as determined by terminal hair counts from baseline to post
      treatment counts. The theory that is widely accepted is that the mitochondria are the
      powerhouse of the stem cells that cause hair growth. The LLLT "turns on" the nutrient pump
      process that energizes the mitochondria, which leads to an increase in ATP and subsequent
      reversal of hair follicles from the dormant stage of growth called telogen, to the active
      growth stage called anagen.

      This specific light system is unclassified by the FDA, from a radiation standpoint, because
      the agency has not developed class designations for LEDs. Currently, it is classified as a
      class II medical device and will be designated as an Over-the-Counter device. It may be
      marketed for hair regrowth, as defined by an increase in terminal hairs and wellness, which
      can be defined as thicker, denser, more supple and darker hair shafts.
    


Study Type

Interventional


Primary Outcome

Terminal Hair Growth


Condition

Androgenetic Alopecia

Intervention

Genix

Study Arms / Comparison Groups

 Genix LLLT Therapeutic Cap
Description:  This is a low-level light device containing 150, 650 nanometer LEDs and 50, 940 nanometer LEDs of equal energy output, fixed at 10 milliwatts in a low profile helmet.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

50

Start Date

August 1, 2020

Completion Date

August 1, 2021

Primary Completion Date

May 1, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Males- age 18-50, females 18 - 70 having Fitzpatrick skin types I-VI.

          -  Androgenetic alopecia by history and clinical examination. Norwood-Hamilton Class
             (IIa-V) and Ludwig-Savin I-II

          -  Having good health and not belonging to any risk group for possible immunodeficiency
             of other chronic systemic diseases that affect hair.

          -  Have a healthy scalp with no anatomical abnormality or suffering with any cutaneous
             disorder that would preclude participation in this study. Subjects suffering with
             dermatological conditions such as seborrheic dermatitis or psoriasis can participate
             provided the scalp is not involved, and no topical treatment is being administered to
             the scalp during the expected period of treatment.

          -  Willingness to answer questions related to Safety and Adverse Effects after each
             treatment.

          -  Willingness to have the required physical examination performed, for the purpose of
             evaluating general health.

          -  Willing to refrain from using any other topical preparation to restore hair, or be
             involved in any treatment aimed at hair restoration. Having participated in any such
             treatment will require a 4-week washout period before commencing study.

        Exclusion Criteria:

          -  Family history of malignant melanoma, or any cutaneous cancer in the head and neck
             area.

          -  Past medical history of malignant melanoma, or other cutaneous neoplasm in the head
             and neck area.

          -  Past Medical History or Family History of Alopecia Areata, or other causes of
             alopecia, or cancer.

          -  Past medical history of collagen-vascular disease, thyroid disease or other cutaneous
             or systemic disease that seriously affects the scalp. (Seborrheic dermatitis or
             psoriasis under good control with therapy and without showing scalp involvement and
             not requiring topical scalp therapy would not be a contraindication.)

          -  Severe androgenetic alopecia (beyond Norwood-Hamilton V or Ludwig-Savin II).

          -  Previous scalp surgery or signs of any scar on the scalp.

          -  Taking chemotherapeutic agents, bronchodilators, decongestants, antiepileptic,
             systemic steroids, topical steroids on the scalp or on greater than 10% body surface
             area or any medication known to cause hair growth.

          -  Having any chronic eye illness, including cataracts, glaucoma, any form of retinal eye
             disease.
      

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Adam Bodian, MD, 973-539-7444, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04558242

Organization ID

DUAL6594


Responsible Party

Sponsor

Study Sponsor

Kiierr International, LLC


Study Sponsor

Adam Bodian, MD, Principal Investigator, Bodian Dermatology Group


Verification Date

September 2020